Long-term bleeding risk prediction in ‘real world’ patients with atrial fibrillation: Comparison of the HAS-BLED and ABC-Bleeding risk scores

2017 ◽  
Vol 117 (10) ◽  
pp. 1848-1858 ◽  
Author(s):  
Vanessa Roldán ◽  
Vicente Vicente ◽  
Mariano Valdés ◽  
Gregory Y. H. Lip ◽  
María Asunción Esteve-Pastor ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Bleeding Score ◽  
Better Than

SummaryRisk scores in patients with atrial fibrillation (AF) based on clinical factors alone generally have only modest predictive value for predicting high risk patients that sustain events. Biomarkers might be an attractive prognostic tool to improve bleeding risk prediction. The new ABCBleeding score performed better than HAS-BLED score in a clinical trial cohort but has not been externally validated. The aim of this study was to analyze the predictive performance of the ABC-Bleeding score compared to HAS-BLED score in an independent “real-world” anticoagulated AF patients with long-term follow-up. We enrolled 1,120 patients stable on vitamin K antagonist treatment. The HAS-BLED and ABC-Bleeding scores were quantified. Predictive values were compared by c-indexes, IDI, NRI, as well as decision curve analysis (DCA). Median HAS-BLED score was 2 (IQR 2–3) and median ABC-Bleeding was 16.5 (IQR 14.3–18.6). After 6.5 years of follow-up, 207 (2.84%/year) patients had major bleeding events, of which 65 (0.89%/year) had intracranial haemorrhage (ICH) and 85 (1.17%/year) had gastrointestinal bleeding events (GIB). The c-index of HAS-BLED was significantly higher than ABC-Bleeding for major bleeding (0.583 vs 0.518; p=0.025), GIB (0.596 vs 0.519; p=0.017) and for the composite of ICH-GIB (0.593 vs 0.527; p=0.030). NRI showed a significant negative reclassification for major bleeding and for the composite of ICH-GIB with the ABC-Bleeding score compared to HAS-BLED. Using DCAs, the use of HAS-BLED score gave an approximate net benefit of 4% over the ABC-Bleeding score. In conclusion, in the first “real-world” validation of the ABC-Bleeding score, HAS-BLED performed significantly better than the ABC-Bleeding score in predicting major bleeding, GIB and the composite of GIB and ICH.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.

P4742Evaluation of the HAS-BLED, ATRIA and ORBIT bleeding risk scores in newly diagnosed non-valvular atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Bergamaschi ◽  
A Stefanizzi ◽  
M Coriano ◽  
P Paolisso ◽  
I Magnani ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Independent Predictor ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Newly Diagnosed ◽  
Bleeding Events ◽  
Hemorrhagic Events ◽  
Major Bleeding Events

Abstract Background Several risk scores have been proposed to assess the bleeding risk in patients with Atrial Fibrillation. Purpose To compare the efficacy of HAS-BLED, ATRIA and ORBIT scores to predict major bleedings in newly diagnosed non-valvular AF (NV-AF) treated with vitamin K antagonists (VKAs) or new oral anticoagulants (NOACs). Methods We analyzed all consecutive patients with AF at our outpatient clinic from January to December 2017. Only those with new diagnosed NV-AF starting new anticoagulant therapy were enrolled. Major hemorrhagic events were defined according to the ISTH definition in non-surgical patients. Results Out of the 820 patients admitted with AF, 305 were newly diagnosed with NV-AF starting oral anticoagulation. Overall, 51.3% were male with a mean age of 72.6±13.7 years. Thirty-six patients (11.8%) started VKAs whereas 269 (88.2%) patients were treated with NOACs. The median follow-up time was 10.4±3.4 months. During follow-up, 123 (32.2%) bleeding events were recorded, 21 (17,1%) in the VKA group and 102 (82,9%) in the NOAC group. Eleven (2.9%) major bleeding events occurred: 5 (45.5%) in the VKA group and 6 (54.5%) in the NOAC group. Overall, patients with major hemorrhagic events showed a mean value of the scores significantly higher when compared to patients without such bleeding complications (HASBLED 3.4 vs 2.4 p=0.007; ATRIA 5.6 vs 2.4 p<0.001; ORBIT 3.6 vs 1.8 p<0,001). Conversely, when analyzing the VKA subgroup, only the ATRIA score was significantly higher in patients with major adverse events (7.4 vs 3.5 p<0.001; HAS-BLED: 4.4 vs 3.6 p=0.27; ORBIT 4.4 vs 2.9 p=0.13). An ATRIA score ≥4 identified patients at high risk of bleeding (29.4% vs. 0% events. respectively, p=0.04). In the NOAC group, patients with major bleeding events had higher mean values of ATRIA (4.0 vs 2.3 p=0.02) and ORBIT (2.8 vs 1.6 p=0,04) but not the HAS-BLED (2.5 vs 2.3 p=0.57) scores. Similarly, patients on NOACs with an ATRIA score ≥4 had higher rates of major bleedings (8.1% vs. 1.6% p=0,02). Comparing the single elements of the ATRIA score, only glomerular filtration rate <30 ml/min/1.73 mq was associated with major bleedings in the VKA group (p<0.001) whereas, in the NOAC group, anemia was strongly associated with bleeding events (p=0,02). In fact, multivariate analysis in the NOAC group showed that hemoglobin level at admission was an independent predictor for major bleeding events (OR 0.41, 95% CI 0.23–0.75, P=0.003). Conversely, in the VKA group, baseline creatinine level was an independent predictor for these events (OR 12.76, 95% CI 1.6–101.7, P=0.016). Conclusions The ATRIA score showed the best efficacy in predicting major bleeding events. Hemoglobin and creatinine levels at admission were independent predictors for major hemorrhagic events in the NOAC and in the VKA groups, respectively. The latter finding might be helpful in stratifying the hemorrhagic risk at the beginning of treatment.

Bleeding risks with frailty and multimorbidity in patients with atrial fibrillation. A nationwide analysis of 1.4 million subjects

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Fauchier ◽  
A Bisson ◽  
A Bodin ◽  
J Herbert ◽  
N Clementy ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Frailty Index ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Frailty Phenotype ◽  
One Year

Abstract Background Frailty and multimorbidity are common in patients with atrial fibrillation (AF). The quantifiable frailty phenotype has been validated as predictive of mortality and disability, and patients can be categorised as frail and non-frail using the Claims-based Frailty Index (CFI). The Charlson comorbidity index (CCI) is a tool to quantify multimorbidity and also a strong estimator of mortality. We evaluated whether frailty and multimorbidity are associated with the risk of major bleeding in patients with AF. Methods Based on the administrative hospital-discharge database, we collected information for all patients with AF between 2010 and 2019 in France. CCI and CFI were calculated for each patient, and their associated risks of bleeding compared to 4 bleeding risk scores (HAS-BLED, HEMORR2HAGES, ATRIA and ORBIT). The analysis focused on patients with events or with at least one year of follow-up. Predictive abilities of the scores were compared in the whole population, and then separately in the subgroup of elderly patients (&gt;75 yo). Results Among 1,372,567 patients with AF, 131,535 major bleeding events were recorded during a follow-up of 3.5±2.1 years (median 3.1, IQR 1.8–4.9) (yearly rate 2.7%). Bleeding occurred more commonly in patients with higher HAS-BLED, ATRIA, CCI and CFI scores. Those with high frailty and multimorbidity had markedly higher yearly incidences of bleeding events of 13.0% and 14.7%, respectively (vs low frailty and multimorbidity: 4.3%% and 4.1%, respectively; p&lt;0.001). The 4 bleeding risk scores significantly had lower c-statistics than CCI and CFI for predicting major bleeding (table). In elderly patients (n=853,833), the c-statistics were all lower than in the whole population and were lower for the 4 scores than for the CCI and CFI scores (0.463, 0.473, 0.443, 0.445, 0.622 and 0.620 for HAS-BLED, ATRIA, ORBIT, HEMORR2HAGES, CCI and CFI, respectively). Conclusion Multimorbidity and frailty, respectively assessed with CCI and CFI, demonstrated statistically better performances in predicting major bleeding than the 4 established bleeding risk scores in AF. Funding Acknowledgement Type of funding source: None

scholarly journals GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e033283 ◽  
Author(s):  
Frederik Dalgaard ◽  
Karen Pieper ◽  
Freek Verheugt ◽  
A John Camm ◽  
Keith AA Fox ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Risk Model ◽  
Oral Anticoagulants ◽  
External Validation ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Secondary Outcome

ObjectivesTo externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort.DesignRetrospective cohort study.SettingDanish nationwide registries.Participants90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year.Primary and secondary outcome measuresExternal validation was performed using discrimination and calibration plots. C-statistics were compared with CHA2DS2VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes.ResultsOf the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66–83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA2DS2VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60).ConclusionIn a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA2DS2VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

P6258Direct oral anticoagulants in non-valvular atrial fibrillation: accuracy of traditional bleeding scores in the elderly

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Novello ◽  
A Graceffa ◽  
C Ninivaggi ◽  
G I Greco ◽  
F Bonfante ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Roc Curves ◽  
Bleeding Risk ◽  
Discriminatory Power ◽  
Risk Scores

Abstract Background Due to the fear of increased risk of bleeding, anticoagulation treatment is underutilized in the prevention of stroke in elderly patients with non-valvular atrial fibrillation (NVAF). Although direct oral anticoagulants (DOAC) are safer than VKA, still little is known about the risk factors associated with bleeding in elderly patients treated with DOAC. Furthermore, it is still uncertain whether the risk scores that are currently used can serve to effectively identify higher bleeding risk in elderly subjects. Purpose The aim of this study was to identify predictors of bleeding in a cohort of elderly people affected by NVAF treated with DOAC, and to evaluate the accuracy of risk scores for bleeding used at present. Methods Data on outpatients aged ≥75 years, naïve for DOAC therapy, who started therapy with Dabigatran, Rivaroxaban, Apixaban or Edoxaban for the prevention of thromboembolism during FANV were analyzed. HASBLED, ATRIA, OBRI and ORBIT scores were calculated for each patient. Patients had follow-up for 12 months during which deaths, therapy discontinuation and adverse events such as thromboembolism and bleeding were reported. Potential predictors of bleeding and the predictive value of each bleeding score were tested using univariate Cox regression; testing accuracy was evaluated using ROC curves. Results A total of 291 patients (52.9% female, mean age 82.85±5.18 years) had a median follow-up time of 11 (10–12) months. The incidence rate of major bleeding was 4.7 per 100 patient-years, the rate of intracranial bleeding was 0.4 per 100 patient-years. Patients who had major bleeding were more often affected by heart failure (63.6% vs 25%; p=0.009) and thrombocytopenia (36.4% vs 7.4%; p=0,009). However in the multivariate analysis only heart failure remained statistically associated with major bleeding (HR 3.83, 95% CI 1.06–13.85; p=0.041). None of tested bleeding risk scores was able to predict major bleeding in our cohort. HASBLED and ORBIT scores were able to predict major and non-major clinically relevant bleeding (HR 1.32; 95% CI 1.01–1.71; p=0.042 and HR 1.20; 95% CI 1.00- 1.43; p=0.046); only the ORBIT score was found to be statistically significant, but with weak discriminatory power at ROC curves (AUC 0.59; 95% CI 0.51–0.68; p=0.041). Conclusions In our cohort of elderly patients aged 75 or older, anticoagulated for NVAF, heart failure history was the only effective predictor of major bleeding risk during DOAC treatment. None of the bleeding risk scores used currently have demonstrated a good discriminatory power in our cohort. As predictive factors of bleedings in DOAC-treated patients may not be the same as those for VKA-treated patients and those in elderly may also be differ in younger people, it calls for more investigation on the topic.

P4748HASBLED score, frailty index or comorbidity index for bleeding risk assessment in patients with atrial fibrillation?

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Fauchier ◽  
A Bisson ◽  
A Bodin ◽  
N Clementy ◽  
B Pierre ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Frailty Index ◽  
Bleeding Risk ◽  
Risk Scores ◽  
P Value ◽  
Bleeding Events ◽  
Predictive Values ◽  
Comorbidity Index

Abstract Background Charlson comorbidity index (CCI) is a tool to measure comorbid disease status and a strong estimator of mortality. The quantifiable frailty phenotype has also been validated as predictive of mortality and disability. Claims data can be used to classify individuals as frail and non-frail using the Claims-based Frailty Index (CFI). We evaluated whether these tools may help to predict the risk of bleeding in patients with atrial fibrillation (AF). Methods All patients with AF seen in an academic institution were identified and followed up for mortality, stroke and bleeding events. HAS-BLED, HEMORR2HAGES, ATRIA and ORBIT scores, CCI and CFI were calculated for each patient. Hazard ratios were calculated and predictive abilities of the scores were compared using the c-statistic in the whole population and then separately in elderly patients (>75 yo). Results Among 8962 patients with AF, 274 major bleeding events were recorded during a follow-up of 874±1054 days. Bleeding occurred more commonly in patients with higher bleeding risk scores, CCI and CFI. The 4 bleeding risk scores significantly had lower c-statistics than CCI and CFI for predicting major bleeding (table). Results were similar whether patients were treated with OAC or no OAC. In elderly patients, the c-statistics were all lower and were not significantly different for the 4 scores, CCI and CFI scores (0.594, 0,572, 0.595, 0.594, 0.616 and 0.591 for HAS-BLED, HEMORR2HAGES, ATRIA, ORBIT, CCI and CFI, respectively). Predictive values for major bleeding ROC Area 95% Conf. Interval P value vs CCI/CFI HASBLED 0.588 0.555–0.621 0.002/0.003 HEMORR2HAGES 0.564 0.531–0.598 <0.0001/<0.0001 ATRIA 0.559 0.522–0.595 <0.0001/<0.0001 ORBIT 0.577 0.542–0.612 0.0002/0.0003 Charlson, CCI 0.652 0.619–0.684 –/0.58 Frailty index, CFI 0.648 0.615–0.681 0.58/– Conclusion Comorbidities and frailty, respectively assessed with CCI and CFI, demonstrated statistically better performances in predicting major bleeding than the 4 established bleeding risk scores in AF, although all c-indexes were broadly similar. The 4 bleeding risk scores, CCI and CFI showed lower performance in predicting bleeding within elderly patients in whom they all performed equally to predict bleeding events. Given their simplicity and similar performances, the user-friendly bleeding risk scores remain attractive tools for the estimation of bleeding risk in elderly patients with AF.

P10 A possible link between sarcopenia and major bleeding risk among patients with atrial fibrillation treated with oral anticoagulation undergoing coronary stenting

2020 ◽  
Vol 41 (Supplement_1) ◽  
Author(s):  
K Tsuchida ◽  
K Tanaka ◽  
K Nakano ◽  
R Akagawa ◽  
N Oyanagi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Skeletal Muscle ◽  
Muscle Mass ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Skeletal Muscle Mass ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Major Bleeding Events

Abstract Background/Introduction In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) with stent implantation, oral anticoagulation (OAC) plus dual antiplatelet therapy (DAPT) increases the risk of bleeding. The PRECISE-DAPT (P-DAPT) and DAPT scores were created to predict increased bleeding versus ischemic risk in patients undergoing DAPT. However, not much information is available on predicting bleeding risk associated with OAC concomitant with DAPT in patients with AF treated with coronary stents. Physical frailty or sarcopenia is considered an emerging predictor for bleeding in AF patients. Purpose To investigate the relationship between skeletal muscle mass and major bleeding risk in AF patients undergoing PCI and subsequent OAC and DAPT. Methods A total of 1,234 consecutive patients after PCI using newer-generation drug eluting stents were evaluated. An anti-thrombotic regimen without OAC was given to 1,077 patients, whereas OAC was required in 157 patients (12.7%) including AF (n = 96). The P-DAPT, DAPT, and HAS-BLED scores were calculated for each of the patients. Any out-of-hospital major bleeding events were identified based on BARC criteria during a median follow-up of 2.9 years. The fat-free mass index (FFMI; kg/m2) was calculated to evaluate skeletal muscle mass as follows: (7.38 + 0.02908 × urinary creatinine (mg/day)) / (height squared (m2)). A Cox proportional hazards model was used to test the significance of the FFMI and these risk scores as predictors of major bleeding, defined as BARC 3 or 5 events in AF patients. The receiver operating characteristic curve (ROC) analyses were used to examine the predictive ability of the FFMI and these scores to identify patients with major bleeding events. Results Major bleeding events were observed in 9 (9.3%) patients. Major bleeding was associated with a lower FFMI (hazard ratio [HR] 0.53; 95% confidence interval [CI] 0.36-0.79; p = 0.002), and higher P-DAPT score (HR, 1.07; 95% CI, 1.02-1.11; p = 0.003), but not with the DAPT (HR, 0.71; 95% CI, 0.45-1.12; p = 0.147) and the HAS-BLED score (HR, 1.00; 95% CI, 0.48-2.09; p = 0.990). In the non-OAC cohort, major bleeding was related to a higher P-DAPT score (HR, 1.05; 95% CI, 1.02-1.07; p &lt; 0.0001), but the FFMI (HR, 0.89; 95% CI, 0.73-1.09; p = 0.265) and the DAPT score were not correlated. C-statistics for major bleeding events were 0.82 (95% CI, 0.71-0.93, p = 0.001) for the FFMI and 0.79 (95% CI, 0.68-0.90, p = 0.004) for the P-DAPT score. Conclusions Assessment of the FFMI for screening sarcopenia is useful to predict major bleedings specifically in patients with AF undergoing coronary stenting. Both the FFMI and P-DAPT could successfully predict major bleedings in AF patients after PCI. Whether novel bleeding risk scores combined with measuring body composition adequately identify high risk patients needs to be validated.

scholarly journals Comparison of bleeding risk scores in patients with atrial fibrillation and cancer

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
D Pastori ◽  
A Marang ◽  
A Bisson ◽  
J Herbert ◽  
GYH Lip ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Bleeding Risk ◽  
Hazard Ratio ◽  
Risk Scores ◽  
Cancer Type ◽  
Gi Bleeding ◽  
Bleeding Events ◽  
Patients With Cancer ◽  
Funding Sources ◽  
Bleeding Score

Abstract Funding Acknowledgements Type of funding sources: None. Background. Cancer may increase bleeding risk in atrial fibrillation (AF), but the association between cancer type and specific bleeding events has been scarcely investigated. Furthermore, the performance of bleeding risk scores in this high-risk subgroup of patients is unclear. Purpose. To describe the incidence rate (IR) of major (MB), gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH) according to cancer types. We also investigated the performance of HAS-BLED, ATRIA and ORBIT scores.  Methods Observational retrospective cohort study including 399,344 patients with AF and cancer. Results. Mean age was 77.9 ± 10.2 years and 63.2% were men. During 2.0 years follow-up, the IR of MB was as high as 8.41%/y, GI bleeding was 3.61%/y and ICH 1.33%/y. MBs were more frequent in liver (12.68%/y), leukaemia (12.39%/y), pancreas (11.71%/y), bladder (11.67%/y) and myeloma (11.64%/y). GI bleedings were highest in liver (7.54%/y), pancreas (7.42%/y) and gastric (5.51%/y). ICH was highest in leukaemia (1.89%/y), myeloma (1.52%/y), lymphoma/liver (1.45%/y) and pancreas (1.41%/y) cancer. The Table shows the hazard ratio and AUC values for each bleeding score. All the three scores significantly associated with bleeding outcomes, with the HAS-BLED score performing better than others for ICH prediction, and the ORBIT score predicting MB and GI bleedings (p &lt; 0.0001 for all AUC comparisons). Conclusions. Cancer increases the risk of bleeding in patients with cancer, with specific differences according to each cancer type. HAS-BLED score showed the best predictive value for ICH and the ORBIT score for MB and GI bleeding. MB GI bleeding ICH Hazard Ratio (95%CI) HASBLED score≥3 6.575 (6.390-6.765) 5.735 (5.502-5.978) 5.803 (5.416-6.218) ATRIA score≥5 5.372 (5.241-5.506) 3.617 (3.499-3.739) 1.469 (1.403-1.538) ORBIT score≥4 13.326 (12.977-13.686) 7.453 (7.202-7.712) 2.578 (2.463-2.699) AUC (95%CI) HASBLED score≥3 0.716 (0.714-0.718) 0.702 (0.699-0.704) 0.698 (0.694-0.702) ATRIA score≥5 0.700 (0.698-0.702) 0.662 (0.659-0.665) 0.563 (0.557-0.568) ORBIT score≥4 0.805 (0.804-0.807) 0.756 (0.753-0.758) 0.641 (0.635-0.646) AUC Difference (95% CI) HASBLED≥3 vs ATRIA≥5 0.016 (0.014-0.018) 0.040 (0.037-0.042) 0.136 (0.133-0.138) HASBLED≥3 vs ORBIT≥4 -0.089 (-0.091–0.087) -0.054 (-0.056–0.052) 0.057 (0.055-0.059) ATRIA≥5 vsORBIT≥4 -0.106 (-0.108–0.104) -0.094 (-0.095–0.092) -0.078 (-0.080–0.076)

scholarly journals Risk definition and outcomes with the application of the PEGASUS-TIMI 54 trial inclusion criteria to a “real world” STEMI population: results from the Italian “CARDIO-STEMI SANREMO” registry

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Sanchez ◽  
Valentina Boasi ◽  
Matteo Vercellino ◽  
Chiara Tacchi ◽  
Pierpaolo Cannarile ◽  
...  
Keyword(s):  
Real World ◽  
Risk Scores ◽  
Hospital Death ◽  
Cumulative Number ◽  
Inclusion Criteria ◽  
Bleeding Events ◽  
Hemorrhagic Risk ◽  
The Impact

Abstract Background The PEGASUS-TIMI 54 trial inclusion criteria effectively identified high-risk patients with recent myocardial infarction (MI) who would benefit from continuing dual antiplatelet therapy (DAPT) with ticagrelor for more than 12 months. It is unknown how many real-world patients meet these criteria during the acute phase of ST-elevation MI (STEMI), or the extent to which these criteria predict a patient's risk and prognosis. Study objectives were: (1) determine the proportion of PEGASUS-TIMI 54-like patients (PG-l) in a real-world cohort of patients hospitalized with STEMI and to assess their ischemic and hemorrhagic risk; (2) examine their ischemic and hemorrhagic in-hospital events (major adverse cardiovascular and cerebrovascular events [MACCE] and clinically relevant bleeding); (3) evaluate their long-term outcomes and the impact on the long-term prognosis of the type of DAPT prescribed at discharge. Methods This observational study was conducted in 1086 patients admitted to hospital with a diagnosis of STEMI between February 2011 and March 2018 and enrolled in the CARDIO-STEMI Sanremo registry. Patients’ demographic and clinical characteristics, procedural variables, and individual ischemic and hemorrhagic risk scores were assessed in-hospital. Four-year survival was also analyzed. Results The proportion of PG-I patients was 69.2%. Compared with non-PG-l patients, PG-l patients were older, had more multivessel disease and comorbidities, and experienced more frequent MACCE (8.3% vs. 3.6%, p = 0.005) and clinically significant bleeding events (6.7% vs. 2.7%, p = 0.008), a higher rate of in-hospital death (6.5% vs. 1.5%, p < 0.001), and higher follow-up mortality rate (14.8% vs. 7.7%; p = 0.002). Four-year survival was significantly lower in the PG-l group (83.9% vs. 91.8%; Log-rank = 0.001) and was related to the cumulative number of concurrent risk factors. In the unadjusted analysis, survival was greater in patients discharged on ticagrelor than on another P2Y12 inhibitor (90.2% vs. 76.7%, Log-rank = 0.001), and the difference was particularly evident in PG-l patients. Conclusions The risk of MACCE for PG-l patients increased with the number of concurrent PEGASUS-TIMI 54 risk features. Treatment with ticagrelor on discharge was associated with improved survival rates during 4 years of follow-up.

P1024Catheter ablation is associated with reduced all-cause mortality in a real-world cohort of patients with atrial fibrillation and heart failure

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Samuel ◽  
M Abrahamowicz ◽  
J Joza ◽  
V Essebag ◽  
L Pilote
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Population Based ◽  
World Population ◽  
Risk Of Death ◽  
All Cause Mortality

Abstract Background Atrial fibrillation (AF) and heart failure (HF) are common co-existing conditions. Randomized trial data suggests a reduction in all-cause mortality with catheter ablation (CA) in selected patients, however, whether these results are replicable in a real-world population and persist in the long-term remains to be shown. Purpose To evaluate the long-term effectiveness of CA in AF-HF patients in reducing the incidence of: a) all-cause mortality b) HF hospitalizations, and c) major morbidities (stroke/transient ischemic attack (TIA) and major bleeding). Methods A population-based administrative cohort was created of AF-HF patients with government prescription coverage in Quebec, Canada (1999–2015). Patients who underwent CA (cases) were matched 1:2 to controls using risk-set sampling. Cases were matched on time in the cohort and frequency of hospitalizations. Measured time-invariant confounders were controlled for using inverse probability of treatment weighting (IPTW) and included age, sex, clinical characteristics, presence of cardiac implantable electronic devices, and medication use. Multivariable Cox models adjusted the association of CA with the outcomes for the time varying confounders of the presence of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT), anticoagulation use (warfarin or direct oral anticoagulation), and any antiarrhythmic (AAD) use during follow-up. For non-fatal outcomes, the competing risk of death was accounted for using the Lunn-McNeil approach. Results Of the 87,676 AF-HF patients, 298 underwent CA and were matched to 591 controls. After IPTW, the distribution of covariates was balanced between cases and controls [age 65.6±11.0 vs 61.6±11.6; women 24% vs 20%; CHA2DS2-Vasc score 3.2±2.3 vs 2.9±2.1; CA vs non-CA, respectively; standardized mean differences <0.1 for all]. Over a median follow-up of 3.3 (IQR 1.1–6.4) years, 19 (7.3%) of CA patients died compared to 144 (24.6%) non-CA patients. After weighting and adjustment, CA was associated with a statistically significant reduction in the incidence of all-cause mortality [adjusted HR 0.5 (95% CI 0.3–0.9)]. In addition, there was no statistically significant difference in the incidence of HF hospitalizations over the follow-up [CA: 22.5% vs non-CA: 27.1%; adjusted HR 0.9 (95% CI 0.6–1.2)]. The incidences of stroke/TIA (1.7% vs 6.8%) and major bleeding (1.7% vs 4.9%) for CA vs non-CA were not statistically different. Conclusion In a matched population-based AF-HF cohort, CA was associated with a reduced risk of all-cause mortality compared to patients who did not undergo CA. Although no difference in the risk of HF hospitalizations, stroke/TIA, and major bleeding was detected between CA and non-CA patients, larger studies are warranted. Acknowledgement/Funding Canadian Institute of Health Research; Fonds de recherché du Quebec-Santé, Clinical Research Scholar Award (V. Essebag) and Doctoral Award (M. Samuel)

scholarly journals The prognostic potential of growth differentiation factor-15 on bleeding events and patient outcome after cardiac surgery

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
N Kazem ◽  
A Hammer ◽  
L Koller ◽  
F Hofer ◽  
B Steinlechner ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Cardiac Surgery ◽  
Major Bleeding ◽  
Bleeding Risk ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Growth Differentiation Factor 15 ◽  
All Cause Mortality

Abstract Background GDF-15 (growth/differentiation factor 15) is induced by myocardial stretch, volume overload, inflammation and oxidative stress. Its expression is tightly linked with cardiovascular events as well as the risk for major bleeding and all-cause mortality. Objective The objective of the present study was to elucidate the prognostic potential of GDF-15 in patients after cardiac surgery. Methods 504 patients undergoing elective cardiac valve and/or coronary artery bypass graft surgery were prospectively enrolled. GDF-15 levels were measured prior surgery to evaluate the impact on bleeding events, thromboembolic events and mortality. Results Preoperative GDF-15 was associated with the primary endpoint of intra- and postoperative red blood cell transfusion (for bleeding risk factors adjusted [adj] OR [odds ratio] per 1-SD [standard deviation] of 1.62 [95% CI: 1.31–2.00]; p&lt;0.001) and postoperative atrial fibrillation (for atrial fibrillation risk factors adj. OR per 1-SD of 1.49 [95% CI: 1.22–1.81]; p&lt;0.001). Higher concentrations of GDF-15 were observed in patients reaching the secondary endpoint of major or clinically relevant minor bleeding (for bleeding risk factors adj. OR per 1-SD of 1.70 [95% CI: 1.05–2.75]; p=0.030) during the 1stpostoperative year, but not for thromboembolic events. GDF-15 was a predictor for cardiovascular mortality (for comorbidities adj. HR [hazard ratio] per 1-SD of 1.67 [95% CI: 1.23–2.27]; p=0.001) and all-cause mortality (for comorbidities adj. HR per 1-SD of 1.55 [95% CI: 1.19–2.01]; p=0.001). A combined risk model of GDF-15 and EuroSCORE II outperformed the EuroSCORE II alone for long-term survival (c-index: 0.75 [95% CI: 0.70–0.80], p=0.046; net reclassification improvement: 33.6%, p&lt;0.001). Conclusion Preoperative GDF-15 concentration is an independent predictor for intra- and postoperative major bleeding, major bleeding during the first year and for long-term cardiovascular or all-cause mortality after cardiac surgery. FUNDunding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Medical University of Vienna Central illustration

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